Systems and methods for protecting umbilical stumps

ABSTRACT

A device for protecting an umbilical stump-catheter interface, includes: a shield having a wall that defines a cavity for accommodating an umbilical stump, wherein the shield further includes a base for attachment to a patient; and an opening at the shield for allowing an umbilical catheter to extend therethrough. A method for protecting an umbilical stump-catheter interface, includes: providing a device having a shield with a wall that defines a cavity for accommodating an umbilical stump, wherein the shield further includes a base for attachment to a patient, and wherein the device further includes an opening at the shield; shielding the umbilical stump from an environment using the shield; and accommodating an umbilical catheter using the opening at the shield.

RELATED APPLICATION DATA

This application is a continuation of U.S. patent application Ser. No.15/098,286 filed on Apr. 13, 2016, which claims priority to, and thebenefit of, U.S. Provisional Patent Application No. 62/156,120 filed May1, 2015, pending, and U.S. Provisional Patent Application No. 62/307,396filed Mar. 11, 2016, pending. The disclosures of all of the aboveapplications are expressly incorporated by reference herein.

FIELD

The field of the application relates to umbilical devices, and moreparticularly, to systems and methods for protecting umbilical stumps.

BACKGROUND

Every year, more than 5 million central venous catheters (also calledcentral lines) are placed by physicians. Central lines facilitate thedelivery of medication and nutritional support to a patient, but canlead to a hospital acquired bloodstream infection. Associated symptomsof central line-associated bloodstream infections (CLABSIs) are sepsis,fever, and malaise. CLABSIs are a major concern for hospitals becausethey have been associated with increased morbidity and mortality, lengthof hospital stay, and cost.

Complications associated with low birth weight and premature infantsmake it necessary for many of these neonates to be admitted to theneonatal intensive care unit (NICU), where a majority of them receivesumbilical catheters. Premature infants are particularly vulnerable tobloodstream infections due to their immature immune systems, poor skinintegrity, exposure to numerous caregivers, placement in an environmentthat is conductive to bacterial colonization, and their subjection torepeated invasive procedures. Indeed, the rate of CLABSIs in theseinfants is far greater than that of adults.

Although umbilical catheterization is a necessary and life-savingprocedure for many premature infants, outcomes from CLABSIs can bedevastating. Catheter-related bloodstream infections in prematureinfants are associated with increased morbidity and mortality. Infantswith CLABSIs have an increased risk for respiratory distress, severeintraventricular hemorrhage, periventricular leukomalacia,bronchopulmonary dysplasia, and death. CLABSIs are the most common causeof complications related to umbilical catheters, with approximately5-15% of neonates with umbilical catheters developing CLABSIs. The rateis highest for the lowest birth weight infants, weighing under 1250grams, who have umbilical catheter CLABSI rates of 15% or more.

Placement of an umbilical catheter is a delicate, multi-step process.First, the cord is elevated vertically and cut approximately onecentimeter above the skin with a scalpel blade. Second, the closed tipsof forceps are entered into the umbilical vein or artery in order todilate the vessel. Third, the catheter is introduced into the vessel andadvanced 4-5 centimeters. This step may be repeated if the catheter isnot properly inserted. Fourth, blood is aspirated to verify catheterplacement in the lumen and 0.5 mL of heparin is flushed to clear thelumen. Finally, the catheter is advanced to a predetermined length(based on height and weight of the neonate), attached to the umbilicalstump with a suture, and the line is secured with a catheter bridge(sometimes made of surgical tape). Ideal placement of an umbilicalvenous catheter is at the junction of the inferior vena cava (IVC) andthe right atrium of the heart.

Despite high complication risks, umbilical catheters remain thepreferred route of catheterization in the NICU because they offerreliable access to the venous system with the necessary flow required todeliver these premature, and often sick, neonates medication, fluids,and parenteral nutrition. Umbilical catheters can also be used tomonitor blood pressure and sample venous or arterial blood. With currenttechnologies, physicians remove the umbilical catheter due to risk ofCLABSI after approximately 6-8 days, even though there is stilltypically a need for central access. Indeed, a peripherally insertedcentral catheter (PICC) line or other form of central catheterization isusually placed in the neonate after UC removal.

Umbilical catheter CLABSIs are at least 5 times more common than centralcatheter associated bloodstream infections. One possible reason for thisis that there is no device that is specific to the unique anatomy of theumbilical area or the unique demands of the neonate that can bothprotect the umbilical stump and stabilize the umbilical catheter(s).

SUMMARY

A device for protecting an umbilical stump-catheter interface, includes:a shield having a wall that defines a cavity for accommodating anumbilical stump, wherein the shield further includes a base forattachment to a patient; and an opening at the shield for allowing anumbilical catheter to extend therethrough.

Optionally, the opening is at a top of the shield.

Optionally, the opening at the top of the shield extends to a side ofthe shield.

Optionally, the shield comprises a first clip configured to hold theumbilical catheter.

Optionally, the shield comprises a second clip.

Optionally, the first clip is above the second clip to form a stackedconfiguration.

Optionally, the first clip and the second clip are disposed at differentrespective sides of the shield.

Optionally, the first clip is made from a first material having a firstdurometer, and another part of the shield is made from a second materialhaving a second durometer, the first durometer being higher than thesecond durometer.

Optionally, the second clip is configured to hold the umbilical catheteror another catheter.

Optionally, the first clip has a first catheter slot, the second cliphas a second catheter slot, the first catheter slot having a dimensionthat is different from a dimension of the second catheter slot.

Optionally, the device further includes a third clip, wherein the firstclip is configured to hold the umbilical catheter, the second clip isconfigured to a first additional catheter, and the third clip isconfigured to hold a second additional catheter or the umbilicalcatheter.

Optionally, the first clip and the second clip are integrated as asingle component.

Optionally, the shield comprises a first portion having a firstdurometer, and a second portion having a second durometer, the firstdurometer being higher than the second durometer.

Optionally, the shield comprises one or more spooling grooves at one ormore sides of the shield, the one or more spooling grooves configured toaccommodate a segment of the umbilical catheter.

Optionally, the shield comprises a circumferentially disposed spoolinggroove configured to accommodate a segment of the umbilical catheter.

Optionally, the shield has a top portion, and wherein the shield furthercomprises a clip at the top portion for holding and/or guiding theumbilical catheter.

Optionally, the shield has a top portion, and wherein the shield furthercomprises at least two pinching protrusions at the top portion forallowing a user to grasp the shield.

Optionally, the shield comprises an exterior surface configured forallowing a user to write on.

Optionally, the shield comprises a color coding or a labeling.

Optionally, the base comprises a T-shape portion, a linear portion, or acurvilinear portion, or a full circumferential portion, extending awayfrom a side of the shield.

Optionally, the shield has a first shield portion and a second shieldportion that is moveably coupled to the first shield portion, whereinwhen the second shield portion is in a first position, the umbilicalstump is shielded by the shield, and when the second shield portion isin a second position, the umbilical stump is exposed to an environmentoutside the shield.

Optionally, the device further includes a mechanical hinge for rotatablycoupling the second shield portion to the first shield portion.

Optionally, the second shield portion is moveable relative to the firstshield portion in a plane that is parallel to the base.

Optionally, the device further includes a securing device for lockingthe second shield portion relative to the first shield portion when thesecond shield portion is in the first position.

Optionally, the device further includes a seal located at or adjacentthe opening, the seal having a first seal portion that is coupled to thefirst shield portion, and a second seal portion that is coupled to thesecond shield portion.

Optionally, at least a part of the shield has a dome shape.

Optionally, the device further includes a tubular structure extendingfrom the dome shape shield, wherein the tubular structure has a channelthat extends from the opening.

Optionally, the tubular structure is at a top of the dome shape shield.

Optionally, the device further includes a seal located at or adjacentthe opening.

Optionally, the seal has a first seal portion and a second seal portionthat cooperates with the first seal portion for securing the umbilicalcatheter relative to the device.

Optionally, a majority of the shield is rigid.

Optionally, the shield is non-rigid, and is collapsible in response to acompress force that is less than 1 lb.

Optionally, the device further includes an adhesive at the base forattaching the base to the patient.

Optionally, the base includes one or more openings or slots forproviding suction.

Optionally, the device further includes a spring-loaded device forsecuring the umbilical catheter relative to the device.

Optionally, at least a part of the shield is transparent.

Optionally, the device further includes a seal for mechanically holdingthe umbilical catheter, wherein the seal is configured to protect theumbilical stump from bacteria associated with the umbilical catheter.

Optionally, the shield is configured to protect the umbilical stump frombacteria outside the shield and/or from physical contact.

Optionally, the shield comprises a vent for allowing some air exchangethrough the wall of the shield.

Optionally, the device further includes a permeable or semipermeablecover covering the vent.

Optionally, the device further includes a cover that can be selectivelyopened to expose the vent or closed to shut the vent.

Optionally, the opening is at a side of the shield.

Optionally, the opening is at an upper portion of the shield and isoffset from a center of the shield.

Optionally, the base, or an entirety, of the shield includes anantimicrobial material.

Optionally, the device further includes an ultraviolet light sourcecoupled to the shield.

Optionally, the shield has a width that is less than 5 inches.

Optionally, the device further includes a manual control mechanismconfigured to shut the umbilical catheter so that fluid flow in theumbilical catheter can be stopped.

Optionally, the device further includes a position monitoring device formonitoring a position of the umbilical catheter with respect to theshield, to the patient, or to the umbilical stump.

A kit includes: the device as described previously; and one or acombination of two or more of: a scissor, a scalpel, a stopcock, asyringe, a measuring tape, a dilator, a needle, a sterilizationmaterial, a catheter, a drape, a sponge, a suture, an umbilical tie, ananesthetic agent, a forceps, a needle holder, a hemostat, a syringe, abag of sterile saline, and a gauze pad.

Optionally, the kit further includes a container having a compartmentfor housing the device, and one or more additional compartment(s) forhousing the scissor, the scalpel, the stopcock, the syringe, themeasuring tape, the dilator, the needle, the sterilization material, thecatheter, the drape, the sponge, the suture, the umbilical tie, theanesthetic agent, the forceps, the needle holder, the hemostat, thesyringe, the bag of sterile saline, the gauze pad, and any combinationof two or more of the foregoing.

A method for protecting an umbilical stump-catheter interface, includes:providing a device having a shield with a wall that defines a cavity foraccommodating an umbilical stump, wherein the shield further includes abase for attachment to a patient, and wherein the device furtherincludes an opening at the shield; shielding the umbilical stump from anenvironment using the shield; and accommodating an umbilical catheterusing the opening at the shield.

Optionally, the device further includes a seal at or adjacent theopening, and wherein the method further comprises protecting theumbilical stump from bacterial associated with the umbilical catheterusing the seal.

Optionally, the method further includes stabilizing the umbilicalcatheter with respect to the device by detachably securing the umbilicalcatheter to the device.

Other and further aspects and features will be evident from reading thefollowing detailed description.

DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of embodiments, in whichsimilar elements are referred to by common reference numerals. Thesedrawings are not necessarily drawn to scale. In order to betterappreciate how the above-recited and other advantages and objects areobtained, a more particular description of the embodiments will berendered, which are illustrated in the accompanying drawings. Thesedrawings depict only exemplary embodiments and are not therefore to beconsidered limiting in the scope of the claims.

FIG. 1 illustrates device for protecting an umbilical stump-catheterinterface.

FIGS. 2A-2B illustrate a shield of the device of FIG. 1, particularshowing the shield having an open-configuration and aclosed-configuration.

FIG. 3A illustrates a catheter seal.

FIG. 3B illustrates the catheter seal of FIG. 3A, with two umbilicalcatheters placed between two seal portions.

FIG. 4 illustrates a base of a shield.

FIG. 5 illustrates a method of using the device of FIG. 1.

FIG. 6 illustrates a kit that includes the device of FIG. 1.

FIG. 7 illustrates another device for protecting an umbilicalstump-catheter interface.

FIGS. 8A-8C illustrate different shields in different embodiments.

FIG. 9A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface.

FIG. 9B illustrates a side view of the device of FIG. 9A, particularlyshowing the device being used with a catheter.

FIG. 9C illustrates a top view of the device of FIG. 9A.

FIG. 10A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 10B illustrates a side view of the device of FIG. 10A.

FIG. 10C illustrates a top view of the device of FIG. 10A.

FIG. 11A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 11B illustrates a side view of the device of FIG. 11A.

FIG. 11C illustrates a top view of the device of FIG. 11A.

FIG. 12A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 12B illustrates a side view of the device of FIG. 12A.

FIG. 12C illustrates a top view of the device of FIG. 12A.

FIG. 13A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 13B illustrates a side view of the device of FIG. 13A.

FIG. 13C illustrates a top view of the device of FIG. 13A.

FIG. 14A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 14B illustrates a side view of the device of FIG. 14A.

FIG. 14C illustrates a top view of the device of FIG. 14A.

FIG. 15A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 15B illustrates a side view of the device of FIG. 15A.

FIG. 15C illustrates a top view of the device of FIG. 15A.

FIG. 16A illustrates a perspective view of another device for protectingan umbilical stump-catheter interface, particularly showing the devicebeing used with a catheter.

FIG. 16B illustrates a side view of the device of FIG. 16A.

FIG. 16C illustrates a top view of the device of FIG. 16A.

FIG. 17 illustrates another device for protecting an umbilicalstump-catheter interface.

FIG. 18 illustrates another device for protecting an umbilicalstump-catheter interface.

FIG. 19A illustrates a device for protecting umbilical stump-catheterinterface, particularly showing the device being used with one catheter.

FIG. 19B illustrates a device for protecting umbilical stump-catheterinterface, particularly showing the device being used with twocatheters.

DETAILED DESCRIPTION

Various embodiments are described hereinafter with reference to thefigures. It should be noted that the figures are not drawn to scale andthat elements of similar structures or functions are represented by likereference numerals throughout the figures. It should also be noted thatthe figures are only intended to facilitate the description of theembodiments. They are not intended as an exhaustive description of theinvention or as a limitation on the scope of the invention. In addition,an illustrated embodiment needs not have all the aspects or advantagesshown. An aspect or an advantage described in conjunction with aparticular embodiment is not necessarily limited to that embodiment andcan be practiced in any other embodiments even if not so illustrated, orif not so explicitly described.

In at least one embodiment, a device for protecting an umbilical stumpis provided. The device may be used to protect an umbilical stump afterumbilical catheterization. The device may also be used to secure, andoptionally seal against, the umbilical catheter in order to reduce therisk of a central-line associated bloodstream infection. In oneimplementation, the device is a rigid, plastic device that covers andisolates a small area around the umbilical catheter insertion site fromthe surrounding environment, and effectively halts bacterial migrationto this area. The device also has an adhesive seal at the base of thedevice for preventing migration of bacteria from the skin into thestump.

FIG. 1 illustrates a device 10 for protecting an umbilicalstump-catheter interface. The device 10 has a shield 20 with a wall 22that defines a cavity 24 for accommodating an umbilical stump 30. Asshown in the figure, the shield 20 further includes a base 40 forattachment to a patient (e.g., a neonate). The device 10 also has anopening 50 at the shield 20 for allowing one or more umbilicalcatheter(s) 60 to extend therethrough.

In the illustrated embodiments, at least a part of the shield 20 has adome shape. In particular, the bottom portion of the shield 20 has adome shape, while a top portion of the shield 20 has a tubular structure62. In other embodiments, the tubular structure 62 may be considered tobe a separate component from the shield 20 (regardless of whether theyare formed together or separately attached to each other). In suchcases, the entirety of the shield 20 may be considered as having a domeshape. As shown in the figure, the tubular structure 62 extends from thedome shape shield 20, and has a channel 64 that extends from the opening50. The tubular structure 62 is at a top of the dome shape shield 20. Inother embodiments, the tubular structure 62 may be extending from thedome shape shield 20 at other locations of the dome shape shield 20.

In other embodiments, the shield 20 may not have a dome shape. Forexample, in other embodiments, the shield 20 may have a rectangular boxshape, a square box shape, a pyramid shape, a cylindrical shape, or anyof other shapes.

Also, in other embodiments, the tubular structure 62 may not extendoutward from the shield 20. For example, in other embodiments, thetubular structure 62 (or at least a part of it) may extend inward intothe cavity 24 defined by the shield 20.

In the illustrated embodiments, the shield 20 has a first shield portion70 and a second shield portion 72 that is moveably coupled to the firstshield portion 70. When the second shield portion 72 is in a firstposition, the umbilical stump 30 is shielded by the shield 20 (see FIGS.1 and 2B), and when the second shield portion 72 is in a secondposition, the umbilical stump 30 is exposed to an environment outsidethe shield 20 (see FIG. 2A).

In the illustrated embodiments, the first shield portion 70 of theshield 20 is rigid, and the second shield portion 72 of the shield 20 isalso rigid. In other embodiments, a part of the shield 20 may beflexible. For example, in other embodiments, the base 40 of the shield20 may be flexible. In some cases, the base 40 may be made from apolymer or a plastic. Also, in some embodiments, a majority of theshield 20 is rigid. Furthermore, in some embodiments, the base 40 may bemade from a material that is more flexible compared to the shield 20. Aflexible base 40 has the advantageous of allowing the base to conformwith a surface profile of a skin of the patient. In addition, in theillustrated embodiments, at least a part of the shield 20 istransparent. This feature allows a physician or a nurse to see thecondition of the umbilical stump 30, the stump-catheter interface, thecatheter coming out from the stump 30, position of catheter, andcatheter marking (if any).

Also, as shown in FIGS. 2A-2B, the device 10 has a mechanical hinge 80for rotatably coupling the second shield portion 72 to the first shieldportion 70. In some cases, the hinge 80 may be implemented using aconnection rod. In other embodiments, the hinge 80 may be implementedusing a flexible plastic that is connected between the first shieldportion 70 and the second shield portion 72. The hinge 80 may be adouble-action hinge, a live hinge, etc. The second shield portion 72 ismoveable relative to the first shield portion 70 in a path that isparallel to a plane of the base 40. In other embodiments, the secondshield portion 72 may be moveable relative to the first shield portion70 in a path that is non-parallel to a plane of the base 40.

Also, in the illustrated embodiments, the device 10 further includes asecuring device 90 for locking the second shield portion 72 relative tothe first shield portion 70 when the second shield portion 72 is in thefirst position. In some cases, the securing device 90 may be a snap-fitconnector. For example, the first shield portion 70 may have one or moreloops 92, and the second shield portion 72 may have one or morecorresponding anchors 94 for snap-fit into the respective loop(s) 92.With this configuration, the first and second shield portions 70, 72 cansnap close, and may be pulled open relative to each other by applying asmall push at the area next to the anchor(s). In other embodiments, thesecuring device 90 may be any of other types of connection mechanism,such as a Velcro, an interference-fit connector, a button, etc.

As shown in FIGS. 1, 3A, and 3B, the device 10 also includes a seal 100located at or adjacent the opening 50 (note that the seal 100 is notshown in FIGS. 2A-2B for clarity). In particular, as shown in FIG. 3A,the seal 100 is located within the channel 64 in the tubular structure62. The seal 100 has a first seal portion 102 that is coupled to thefirst shield portion 70 (or to a first part of the tubular structure62), and a second seal portion 104 that is coupled to the second shieldportion 72 (or to a second part of the tubular structure 62). The firstseal portion 102 and the second seal portion 104 are configured tocooperate with each other for securing the umbilical catheter 60relative to the device 10. In particular, the seal 100 is configured formechanically holding the umbilical catheter 60 in a vertical positionlike that shown in FIG. 3B. In other embodiments, the seal 100 may beconfigured to hold the umbilical catheter 60 at other orientationsrelative to the patient. For example, in other embodiments, the tubularstructure 62 with the seal 100 may be oriented horizontally or at anacute angle relative to a vertical axis.

In some embodiments, the material and/or the size and shape of the seal100 can be selected so that the resulting seal 100 can provide a desiredfrictional force that impedes catheter movement relative to the seal100, while providing a compliance that does not collapse orover-compress the catheter (to impede fluid flow). Accordingly, in someembodiments, the closing of the seal portions 102, 104 functions tosecure the catheter relative to the seal 100. Also, in some cases, thelongitudinal dimension of the seal (i.e., along the direction of thecatheter) can be increased to further improve contact area between theseal 100 and the catheter.

As discussed, the seal 100 may be at or adjacent the opening 50. In somecases, the seal 100 may be considered as being “at” the opening 50 ifany part of the seal 100 intersects a cross section of the opening 50.Also, in some cases, no part of the seal 100 intersects a cross sectionof the opening 50. In such cases, the seal 100 may be considered to be“adjacent” the opening 50 if a spacing between the seal 100 and theopening 50 (measured along a longitudinal axis of the tubular structure62) is less than 3 cm, and more preferably less than 1 cm.

In one implementation, the first seal portion 102 and the second sealportion 104 may be made from rubber (e.g., neoprene rubber). The firstseal portion 102 and the second seal portion 104 may have a shorehardness of 70 that allows the seal portions 102, 104 to deform aroundthe catheter(s) 60. This secures the catheter(s) 60 without occludingthem due to compression by the seal portions 102, 104. In otherembodiments, the seal portions 102, 104 may have other hardness. Asshown in FIG. 3A, before the seal portions 102, 104 are used to clamparound the catheter(s) 60, the seal portions 102, 104 have respectivesurfaces that face towards each other, wherein the surfaces are planar.When one or more catheter(s) 60 are placed between the seal portions102, 104, and when the seal portions 102, 104 are used to grip aroundthe catheter(s) 60, the opposing surfaces of the seal portions 102, 104deform around the catheter(s) 60 (see FIG. 3B). Such configuration isadvantageous because it allows the seal 100 to form a physical barrierto prevent bacteria from outside the device 10 to travel into the cavity24. Such configuration is also advantageous because it allows the seal100 to stabilize different sized catheters. In other embodiments,instead of the opposing planar surfaces that deform in response toplacement of the catheter(s) there between, the seal portions 102, 104may have one or more pre-formed channels for accommodating respectivecatheter(s) 60.

Also, in some embodiments, the seal portions 102, 104 may have asufficiently high friction that allows the seal portions 102, 104 toprevent movement of the catheter(s) 60 when the seal portions 102, 104are closed around the catheter(s) 60. In some cases, the friction may besufficient to prevent self-movement between the catheter(s) 60 and theseal 100, while allowing a physician to manually slide the seal 100relative to the catheter(s) 60. In other embodiments, the friction maybe sufficiently high to prevent a physician from manually sliding theseal 100 relative to the catheter(s) 60.

In the illustrated embodiments, the seal 100 is configured to protectthe umbilical stump 30 from bacteria associated with the umbilicalcatheter 60, while the shield 20 is configured to protect the umbilicalstump 30 from bacteria from environment outside the shield 20.

As shown in FIG. 4, the device 10 also includes an adhesive 142 at thebase 40 for attaching the base 40 to the patient. In one implementation,the adhesive 142 may be a double-sided tape, with a first side attachedto a bottom surface of the base 40, and a second side (opposite from thefirst side) facing downward. The device 10 may also include a tape cover144 covering the second side of the adhesive 142. Since a neonate's skinis particularly sensitive to irritation and damage, the strength andchemical composition of the adhesive 142 may be designed to protect theneonate's skin. In one implementation, a hydrocolloid gel may be used toimplement the adhesive 142. Such an adhesive may have minimal skinirritation over a long period of time.

FIG. 5 illustrates a method of using the device 10. First, the device 10is provided. As discussed, the device 10 includes a shield 20 with awall 22 that defines a cavity 24 for accommodating an umbilical stump30, wherein the shield 20 further includes a base 40 for attachment to apatient. In some embodiments, the act of providing the device 10 may beperformed by a manufacturer of the device 10. In other embodiments, theact of providing the device 10 may be performed by an importer of thedevice 10. In further embodiments, the act of providing the device 10may be performed by a distributer, a hospital, a physician, or a nurse.

Before the device 10 is used to shield the umbilical stump 30, theadhesive tape 144 is removed from the adhesive 142 (see FIG. 4). Afterthe bottom surface of the adhesive 142 is exposed, the shield 20 is thenplaced over the umbilical stump 30, and the base 40 of the shield 20 isthen attached to the patient using the adhesive 142. In someembodiments, as the base 40 is being attached to the patient, the firstshield portion 70 and the second shield portion 72 are closed relativeto each other, thereby closing the first and second seal portions 102,104 towards the umbilical catheter 60. In other embodiments, the firstshield portion 70 and the second shield portion 72 may be closedrelative to each other first, to thereby close the seal portions 102,104 to grip the umbilical catheter 60. The shield 20 is then moved downtowards the patient's skin to secure the base 40 on the patient's skin.As the shield 20 is moved down, the seal portions 102, 104 surroundingthe umbilical catheter 60 slide relative to the umbilical catheter 60while the umbilical catheter 60 is confined within the space definedbetween the seal portions 102, 104.

In the illustrated embodiments, the opening 50 at the shield 20 allowsthe umbilical catheter 60 to extend through the shield 20 while theumbilical catheter 60 is gripped between the seal portions 102, 104.Accordingly, the opening 50 at the shield 20 accommodates the umbilicalcatheter 60.

After the shield 20 is placed around the umbilical stump 30, theumbilical stump 30 is then shielded from an environment using the shield20. The seal 100 formed by the seal portions 102, 104 also protects theumbilical stump 30 from bacterial associated with the umbilical catheter60. In addition, the adhesive 142 at the base 40 prevents bacteria atthe skin outside the shield 20 from reaching the umbilical stump 30.

As shown in the above embodiments, the device 10 is advantageous because(1) it isolates the area around the catheter insertion site fromsurrounding environment to prevent or at least reduce bacterialmigration to this area from the air, (2) its adhesive 142 below the base40 functions as a seal that prevents or at least reduce migration ofbacteria from the skin into the umbilical stump and attaches the device10 to the skin, and (3) the seal 100 secures the catheter(s) 60 relativeto the shield 20 and prevents or at least reduce bacterial migrationfrom the catheter(s) 60 into the umbilical stump. These benefits wouldlead to a reduction in neonate morbidity and mortality, would increasethe ease of neonate care in the NICU, and may reduce cost of care. Also,the device 10 is advantageous because it does not interfere with currentumbilical catheterization procedures. This allows the integration of thedevice 10 into current practice easy. The device 10 is also easy to use.

In one or more embodiments described herein, the device 10 forprotecting the umbilical stump-catheter interface may be a part of akit. FIG. 6 illustrates a kit 300 that includes the device 10. In theillustrated embodiments, the kit 300 also includes a scissor 302, one ormore sterilization material(s) 304, and one or more umbilical catheters306. By means of non-limiting examples, a sterilization material may bechlorhexidine, betadine, etc. The kit 300 also includes a container 310having a plurality of compartments 312 for housing the device 10, thescissor 302, the one or more sterilization materials 304, and the one ormore umbilical catheters 306, respectively. It should be noted that thekit 300 is not limited to the configuration shown, and that the kit 300may have other configurations in other embodiments. For example, inother embodiments, instead of having all of the items shown, the kit 300may include the device 10, and one or a combination of: a scissor, asterilization material, and an umbilical catheter. In other embodiments,instead of only having the items aforementioned, the kit 300 may includeadditional materials. The kit 300 is advantageous because it provides anintegrated solution. In particular, the kit 300 may include tools thatare involved in the placement of umbilical catheter, and also the device10 for protecting the umbilical stump 30. During use, the physician ornurse can use the sterilization material 304 in the kit 300 fordisinfection of a treatment site. After the treatment site at thepatient has been disinfected, the physician or nurse can then apply theumbilical catheter 306 in the kit 300 on the patient. If any cutting isneeded in the process, the physician or nurse can also use the scissor302 in the kit 300. Furthermore, the physician or nurse can use thedevice 10 in the kit 300 to shield and protect the umbilical stumpagainst bacterial infection associated with the catheter and/or theenvironment surrounding the patient (e.g., by preventing the umbilicalstump from being in physical contact with objects and/or substancesoutside the shield).

It should be noted that the kit 300 is not limited to having the aboveitems, and that the kit 300 may include other items in otherembodiments. For example, in other embodiments, in addition to includingthe device 10, the kit 300 may include one or a combination of: ascissor, a scalpel, a stopcock, a syringe, a measuring tape, a dilator,a needle, a sterilization material, a catheter, a drape, a sponge, asuture, an umbilical tie, an anesthetic agent, a forceps, a needleholder, a hemostat, a syringe, a bag of sterile saline, and a gauze pad.Also, the container 310 of the kit 300 may have a compartment forhousing the device 10, and one or more additional compartment(s) forhousing one or a combination of: a scissor, a scalpel, a stopcock, asyringe, a measuring tape, a dilator, a needle, a sterilizationmaterial, a catheter, a drape, a sponge, a suture, an umbilical tie, ananesthetic agent, a forceps, a needle holder, a hemostat, a syringe, abag of sterile saline, and a gauze pad.

It should be noted that the device 10 should not be limited to theexamples described above, and that the device 10 may have otherconfigurations in other embodiments. For example, as shown in FIG. 7, inother embodiments, instead of, or in addition to, using the adhesive142, the shield 20 of the device 10 may include a channel 400 within thewall 22 of the shield 20. The channel 400 may be defined by the wall 22of the shield 20. Alternatively, the channel 400 may be in a separatetube that is located inside the wall of the shield 20. The channel 400is in fluid communication with opening(s) or slot(s) 402 at the bottom(base 40) of the shield 20 where the shield 20 interfaces with the skinof the patient. During use, a syringe 410 may be coupled to an opening420 at the wall 22 of the shield 20, and the syringe 410 may then beused to apply suction inside the channel 400. The suction causes thepatient's skin to be pulled towards the opening(s) or slot(s) 402 at thebottom of the shield 20, thereby securing the skin relative to theshield 20. After sufficient suction has been applied, a cover 430 maythen be used to cover up the opening 420.

In some cases, the opening 420 may include a one-way valve. This allowsthe syringe 410 to remove air within the channel 400 in one direction tocreate suction within the channel 400, and after the syringe 410 isremoved from the opening 420, air will not leak back into the channel400. If the device 10 is to be decoupled from the patient, the device 10may be pulled away from the skin, or the patient skin next to the base40 may be pressed, thereby allowing air to leak back into the channel400. In further embodiments, a pin or a rod may be inserted into theone-way valve in the opening 420 to open up the valve, thereby allowingair to leak back into the channel 400 to remove the suction.

Also, in one or more embodiments described herein, instead of using theseal 100, the device 10 may include a spring-loaded device 450 (likethat shown in FIG. 7) at the tubular structure 62, for securing thecatheter 60 relative to the device 10. The spring-loaded device 450 mayinclude an engagement member 452 located inside the channel 64 of thetubular structure 62, and a spring 454 for biasing the engagement member452 to push the engagement member 452 into the channel 64 inside thetubular structure 62. When the catheter 60 is placed inside the channel64, the user may pull the tap 456 at the spring-loaded device 450 toallow the catheter 60 to be inserted into the channel 64. When thecatheter 60 is desirably positioned relative to the tubular structure62, the tap 456 may then be released to allow the engagement member 452to be pushed by the spring 454 towards the catheter 60 to thereby securethe catheter 60 in place. In some cases, the engagement member 452 maybe a pin, and the catheter 60 may have multiple openings/indentations460, wherein the pin may be selectively placed into a one of theopenings/indentations 460. In other embodiments, the catheter 60 mayhave a smooth surface, and the engagement member 452 may be configuredto secure the catheter 60 by friction.

In one or more embodiments described herein the shield 20 may optionallyfurther include one or more vents. FIG. 8A illustrates an embodiment ofthe shield 20, particularly showing the shield 20 having multiple vents800. The vents 800 may be advantageous in that they may prevent a“bio-dome” like effect (which may cause an increase of bacterial load)within the cavity of the shield 20. Also, the vent(s) 800 may allowumbilical stump to dry and prevent further bacterial growth. The vents800 may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800. Also, in some embodiments, theshield 20 may include vents with different sizes, or vents with the samesize. In further embodiments, the vents may include respective coversthat may be selectively opened or closed, thereby allowing a user toselectively choose to allow more air flow or air exchange across theshield 20. Each cover may be in a form of a door that is rotatablycoupled to the shield 20 that can be opened or closed to shut the vent.Alternatively, each cover may be in a form of a tape, that may beselectively peeled off by the user to open the vent.

Also, in other embodiments, the vents 800 at the shield 20 may be largerthan those show in FIG. 8A. For example, as shown in FIG. 8B, in otherembodiments, the shield 20 may have relatively larger vents 800.

In addition, in the illustrated embodiments, the vents 800 at the shield20 all have the same size. In other embodiments, at least two of thevents 800 at the shield 20 may be in different sizes.

Furthermore, as shown in FIG. 8C, in other embodiments, the vent(s) 800at the shield 20 may be covered by permeable or semipermeable cover(s)802. The cover(s) 802 is advantageous because it further limits anamount of air exchange and/or bacterial entry through the wall of theshield 20.

It should be noted that the device 10 is not limited to having the aboveconfigurations and features, and that the device 10 may have otherconfigurations and features in other embodiments.

For example, FIGS. 9A-9C illustrate another device 10 for protecting anumbilical stump-catheter interface. The device 10 includes a shield 20having a wall 22 that defines a cavity 24 for accommodating an umbilicalstump. The shield 20 further includes a base 40 for attachment to apatient. In some cases, the base 40 may include an adhesive that allowsthe base 40 to be attached to the patient. The device 10 includes anopening 50 at the shield 20 for allowing an umbilical catheter 60 toextend therethrough. The shield 20 has a tubular structure 62 at the topof the shield, which functions as a stabilizer to stabilize theumbilical catheter 60 while the umbilical catheter 60 is accommodated inthe opening 50. In other embodiments, the shield 20 may not include thetubular structure 62. As shown in the figures, the opening 50 is locatedat a top of the shield 20, and extends to a side of the shield 20,thereby defining a linear slot 901 at the side of the shield 20. Thisconfiguration is advantageous because it allows the shield 20 to beplaced around the umbilical catheter 60 by sliding the catheter 60through the slot at the side of the shield 20. The shield 20 can then beslid down to cover the umbilical stump. Also, the above configuration isadvantageous because it allows the catheter 60 to exit from the opening50 at any angle relative to the shield 20.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a first portion 902 a, a second portion 902 b, and a thirdportion 902 c disposed at different respective sides of the shield 20.The portions 902 a-902 c define respective slots 904 a-904 c foraccommodating the umbilical catheter 60 when the umbilical catheter 60is wrapped around the shield 20. As shown in the figures, each of theportions 902 a-902 c has a first cross section at an outermost radialdistance from a center of the shield 20, and a second cross section thatis smaller than the first cross section at a radial distance that iscloser to the center of the shield 20. This configuration forms ananchor to reduce the risk that the umbilical catheter 60 will moveradially outward and unwrap itself from the shield 20. Although threeportions 902 a-902 c are shown, in other embodiments, the device 10 mayinclude only a single portion 902, two portions 902, or more than threeportions 902.

FIGS. 10A-10C illustrate another device 10 for protecting an umbilicalstump-catheter interface. The device 10 includes a shield 20 having awall 22 that defines a cavity 24 for accommodating an umbilical stump.The shield 20 further includes a base 40 for attachment to a patient. Insome cases, the base 40 may include an adhesive that allows the base 40to be attached to the patient. The device 10 includes an opening 50 atthe shield 20 for allowing an umbilical catheter 60 to extendtherethrough. The shield 20 has a tubular structure 62 at the top of theshield, which functions as a stabilizer to stabilize the umbilicalcatheter 60 while the umbilical catheter 60 is accommodated in theopening 50. In other embodiments, the shield 20 may not include thetubular structure 62. As shown in the figures, the opening 50 is locatedat a top of the shield 20, and extends to a side of the shield 20,thereby defining a linear slot at the side of the shield 20. Thisconfiguration is advantageous because it allows the shield 20 to beplaced around the umbilical catheter 60 by sliding the catheter 60through the slot at the side of the shield 20. The shield 20 can then beslid down to cover the umbilical stump.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a, 940 b disposed at differentrespective sides of the shield 20. The clips 940 a, 940 b are configuredto detachably hold the umbilical catheter 60 outside the shield 20. Eachof the clips 940 a, 940 b has a first clip portion 944 and a second clipportion 946. The first and second clip portions 944, 946 are separatedfrom each other by a distance to define a clip cavity 948 therebetween.The clip cavity 948 is sized such that the umbilical catheter 60 can befrictionally pushed therein. In the illustrated embodiments, the clipcavity 948 has a first width at the outermost part of the clip 940, anda second width larger than the first width at an inner part of the clip940. With such configuration, the umbilical catheter 60 will experiencea higher friction when initially being pushed radially into the clipcavity 948 of the clip, and once the umbilical catheter 60 passes theoutermost part of the clip 940, the umbilical catheter 60 will beaccommodated in the inner part of the clip with the larger second width.In some cases, when the umbilical catheter 60 is accommodated in theinner part of the clip 940, the umbilical catheter 60 may experience noclamping force by the clip portions 944, 946. In other cases, theumbilical catheter 60 may experience a slight clamping force by the clipportions 944, 946 that is less compared to the clamping force when theumbilical catheter 60 is being pushed into the clip 940 at the outermost part of the clip 940. In other embodiments, instead of the clipcavity 948 having a larger width at an inner part of the clip 940compared to the outer part of the clip 940, the clip cavity 948 may havea uniform width extending from the outer part of the clip 940 to aninner part of the clip 940. In further embodiments, the clip cavity 948may have a decreased width at the inner part of the clip 940 compared tothe outer part of the clip 940. Although two clips 940 a, 940 b areshown, in other embodiments, there may be only one clip 940, or morethan two clips 940.

It should be noted that the clip 940 is not limited to the configurationshown, and may have other configurations in other embodiments. Forexample, instead of having two opposite portions for frictionallygrasping the umbilical catheter 60, the clip 940 may include more thantwo portions (e.g., three portions) that circumferentially engage withdifferent circumferential parts of the umbilical catheter 60.

Also, in the illustrated embodiments, the shield 20 includes acircumferentially disposed spooling groove 942 for accommodating asegment of the umbilical catheter 60 while the segment of the umbilicalcatheter 60 is wrapped around the shield at the spooling groove 942. Thespooling groove 942 may be partially or completely circumferentiallydisposed around the shield 20. Although only one spooling groove 942 isshown, in other embodiments, the shield 20 may have multiple spoolinggrooves 942. For example, there may be a first spooling groove, and asecond spooling groove, wherein the first spooling groove is above thesecond spooling groove to form a stacked configuration.

In other embodiments, the device 10 may not include any spooling groove.Instead, the umbilical catheter 60 may be wrapped around an exteriorsurface of the shield 20, with a direction of the umbilical catheter 60being defined by one or more of the clips 940.

FIGS. 11A-11C illustrate another device 10 for protecting an umbilicalstump-catheter interface. The device 10 includes a shield 20 having awall 22 that defines a cavity 24 for accommodating an umbilical stump.The shield 20 further includes a base 40 for attachment to a patient. Insome cases, the base 40 may include an adhesive that allows the base 40to be attached to the patient. The device 10 includes an opening 50 atthe shield 20 for allowing an umbilical catheter 60 to extendtherethrough. As shown in the figures, the opening 50 is located at atop of the shield 20, and extends to a side of the shield 20, therebydefining a linear slot at the side of the shield 20. This configurationis advantageous because it allows the shield 20 to be placed around theumbilical catheter 60 by sliding the catheter 60 through the slot at theside of the shield 20. The shield 20 can then be slid down to cover theumbilical stump.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a, 940 b disposed at differentrespective sides of the shield 20. The clips 940 a, 940 b are configuredto detachably hold the umbilical catheter 60 outside the shield 20.Although two clips 940 a, 940 b are shown, in other embodiments, theremay be only one clip 940, or more than two clips 940. The features ofthe clips 940 are similar to those described with reference to FIG. 10A,and therefore will not be repeated here.

Also, in the illustrated embodiments, the shield 20 includes acircumferentially disposed spooling groove 942 for accommodating asegment of the umbilical catheter 60 while the segment of the umbilicalcatheter 60 is wrapped around the shield at the spooling groove 942. Thespooling groove 942 may be partially or completely circumferentiallydisposed around the shield 20. Although only one spooling groove 942 isshown, in other embodiments, the shield 20 may have multiple spoolinggrooves 942. For example, there may be a first spooling groove, and asecond spooling groove, wherein the first spooling groove is above thesecond spooling groove to form a stacked configuration.

In other embodiments, the device 10 may not include any spooling groove.Instead, the umbilical catheter 60 may be wrapped around an exteriorsurface of the shield 20, with a direction of the umbilical catheter 60being defined by one or more of the clips 940.

Unlike the embodiments shown in FIG. 10A, the shield 20 in theembodiments of FIGS. 11A-11C does not have the tubular structure 62 atthe top of the shield. No stabilizing structure is needed at the top ofthe shield 20 because the umbilical catheter 60 can be stabilized withrespect to the shield 20 by holding the catheter 60 with the clip 920(with a length of the segment of the catheter 60 between the clip 920and the opening 50 being as short as possible), by wrapping theumbilical catheter 60 around the spooling groove 924, or by acombination of both.

In addition, unlike the embodiments shown in FIG. 10A, the inner part ofthe clip cavity 948 in the embodiments of FIGS. 11A-11C is much larger,thereby allowing multiple segments of the umbilical catheter 60 to beplaced therein when the umbilical catheter 60 is wrapped around theshield 20 multiple times.

Also, unlike the embodiments shown in FIG. 10A, the spooling groove 942shown in the embodiments of FIGS. 11A-11C is deeper, thereby allowingthe umbilical catheter 60 to be wrapped around the shield 20 multipletimes within the spooling groove 942.

In any of the embodiments described herein, the device 10 may have morethan one spooling groove 942 for allowing the umbilical catheter 60 towrap around the shield 20. For example, FIGS. 12A-12C illustrate anotherdevice 10 for protecting an umbilical stump-catheter interface,particularly showing the umbilical stump device 10 having multiplespooling grooves. The device 10 includes a shield 20 having a wall 22that defines a cavity 24 for accommodating an umbilical stump. Theshield 20 further includes a base 40 for attachment to a patient. Insome cases, the base 40 may include an adhesive that allows the base 40to be attached to the patient. The device 10 includes an opening 50 atthe shield 20 for allowing an umbilical catheter 60 to extendtherethrough. As shown in the figures, the opening 50 is located at atop of the shield 20, and extends to a side of the shield 20, therebydefining a linear slot at the side of the shield 20. This configurationis advantageous because it allows the shield 20 to be placed around theumbilical catheter 60 by sliding the catheter 60 through the slot at theside of the shield 20. The shield 20 can then be slid down to cover theumbilical stump.

In the illustrated embodiments, the shield 20 includes a firstcircumferentially disposed spooling groove 942 a for accommodating asegment of the umbilical catheter 60 while the segment of the umbilicalcatheter 60 is wrapped around the shield at the spooling groove 942 a.The shield 20 also includes a second circumferentially disposed spoolinggroove 942 b for accommodating a segment of the umbilical catheter 60while the segment of the umbilical catheter 60 is wrapped around theshield at the spooling groove 942 b. The first spooling groove 942 a isabove the second spooling groove 942 b to form a stacked configuration.Each of the spooling grooves 942 a, 942 b may be partially or completelycircumferentially disposed around the shield 20. Although two spoolinggrooves 942 a, 942 b are shown, in other embodiments, the shield 20 mayhave only one spooling groove, or more than two spooling grooves 942.

In other embodiments, the device 10 may not include any spooling groove.Instead, the umbilical catheter 60 may be wrapped around an exteriorsurface of the shield 20, with a direction of the umbilical catheter 60being defined by one or more of the clips 940.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a-940 d disposed at differentrespective sides of the shield 20. The clips 940 a-940 d are configuredto detachably hold the umbilical catheter 60 outside the shield 20. Theclips 940 are similar to that described in previous embodiments, exceptthat the opening between the clip portions is made smaller to form avery narrow slit. In some cases, the slit has a zero dimension so thatthe two clip portions at the exterior portion of the clip 940 abutagainst each other. This configuration is advantageous because once thecatheter 60 is pushed through the slit, and is placed in the largeropening at the inner part of the clip 940, the exterior part of the clip940 where the slit is defined will prevent the catheter 60 from fallingout of the clip 940.

FIGS. 13A-13C illustrate another device 10 for protecting an umbilicalstump-catheter interface. The device 10 includes a shield 20 having awall 22 that defines a cavity 24 for accommodating an umbilical stump.The shield 20 further includes a base 40 for attachment to a patient. Insome cases, the base 40 may include an adhesive that allows the base 40to be attached to the patient. The device 10 includes an opening 50 atthe shield 20 for allowing an umbilical catheter 60 to extendtherethrough. As shown in the figures, the opening 50 is located at atop of the shield 20, and extends to a side of the shield 20, therebydefining a linear slot at the side of the shield 20. This configurationis advantageous because it allows the shield 20 to be placed around theumbilical catheter 60 by sliding the catheter 60 through the slot at theside of the shield 20. The shield 20 can then be slid down to cover theumbilical stump.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a-940 d disposed at differentrespective sides of the shield 20. The clips 940 a-940 d are configuredto detachably hold the umbilical catheter 60 outside the shield 20. Eachof the clips 940 a-940 d has a first clip portion 944, a second clipportion 946, and a third clip portion 950. The first and second clipportions 944, 946 are separated from each other by a distance to definea first clip cavity 948 a therebetween. The second and third clipportions 946, 950 are separated from each other by a distance to definea second clip cavity 948 b. The clip cavity 948 a/948 b is sized suchthat the umbilical catheter 60 can be frictionally pushed therein. Inthe illustrated embodiments, the clip cavity 948 a/948 b has a firstwidth at the outermost part of the clip 940, and a second width largerthan the first width at an inner part of the clip 940. With suchconfiguration, the umbilical catheter 60 will experience a higherfriction when initially being pushed radially into the clip cavity 948a/948 b of the clip, and once the umbilical catheter 60 passes theoutermost part of the clip 940, the umbilical catheter 60 will beaccommodated in the inner part of the clip with the larger second width.In some cases, when the umbilical catheter 60 is accommodated in theinner part of the clip 940, the umbilical catheter 60 may experience noclamping force by the clip portions 944, 946, or by the clip portions946, 950 (depending whether the clip cavity 948 a or the clip cavity 948b is being used). In other cases, the umbilical catheter 60 mayexperience a slight clamping force by the clip portions 944, 946, or bythe clip portions 946, 950 that is less compared to the clamping forcewhen the umbilical catheter 60 is being pushed into the clip 940 at theouter most part of the clip 940. In other embodiments, instead of theclip cavity 948 a/948 b having a larger width at an inner part of theclip 940 compared to the outer part of the clip 940, the clip cavity 948a/948 b may have a uniform width extending from the outer part of theclip 940 to an inner part of the clip 940. In further embodiments, theclip cavity 948 a/948 b may have a decreased width at the inner part ofthe clip 940 compared to the outer part of the clip 940. Although fourclips 940 a-940 d are shown, in other embodiments, there may be fewerthan four clips 940, or more than four clips 940.

In the illustrated embodiments, each clip 940 has multiple stacked slots948 for allowing a user to couple the umbilical catheter 60 to aselected one of the slots 948, and/or for allowing a user to wrap theumbilical catheter 60 around the shield 20 multiple times. In otherembodiments, the number of slots 948 in each clip 940 may be more thantwo (e.g., three, four, etc.). Also, it should be noted that the stackedslots 948 feature is not limited to the embodiments of FIGS. 13A-13C,and that other embodiments described herein may optionally include thestacked slots feature.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

Also, in the illustrated embodiments, the shield 20 includes acircumferentially disposed spooling groove 942 for accommodating asegment of the umbilical catheter 60 while the segment of the umbilicalcatheter 60 is wrapped around the shield at the spooling groove 942. Thespooling groove 942 may be partially or completely circumferentiallydisposed around the shield 20. Although only one spooling groove 942 isshown, in other embodiments, the shield 20 may have multiple spoolinggrooves 942. For example, there may be a first spooling groove, and asecond spooling groove, wherein the first spooling groove is above thesecond spooling groove to form a stacked configuration.

In other embodiments, the device 10 may not include any spooling groove.Instead, the umbilical catheter 60 may be wrapped around an exteriorsurface of the shield 20, with a direction of the umbilical catheter 60being defined by one or more of the clips 940.

In any of the embodiments described herein, the device 10 may optionallyfurther include a top clip for detachably securing the umbilicalcatheter 60 at a top cover of the shield 20. For example, FIGS. 14A-14Cillustrate another device 10 for protecting an umbilical stump-catheterinterface. The device 10 includes a shield 20 having a wall 22 thatdefines a cavity 24 for accommodating an umbilical stump. The shield 20further includes a base 40 for attachment to a patient. In some cases,the base 40 may include an adhesive that allows the base 40 to beattached to the patient. The device 10 includes an opening 50 at theshield 20 for allowing an umbilical catheter 60 to extend therethrough.As shown in the figures, the opening 50 is located at a top of theshield 20, and extends to a side of the shield 20, thereby defining alinear slot at the side of the shield 20. This configuration isadvantageous because it allows the shield 20 to be placed around theumbilical catheter 60 by sliding the catheter 60 through the slot at theside of the shield 20. The shield 20 can then be slid down to cover theumbilical stump.

In the illustrated embodiments, the device 10 also includes a top clip960 located at the upper portion of the shield 20 for detachablysecuring the umbilical catheter 60 relative to the shield 20. The clip960 includes a first clip portion 962 and a second clip portion 964. Thefirst and second clip portions 962, 964 are separated from each other bya distance to define a slot 966. The slot 966 is sized so that theumbilical catheter 60 may be frictionally pushed therein and be clampedby the first and second clip portions 962, 964. The top clip 960 isadvantageous because it not only secures the umbilical catheter 60relative to the top portion (cover) of the shield 20, but it alsodirects the umbilical catheter 60 towards a bottom portion of the shield20 where the clips 940 a-940 d are located, so that after a firstsegment of the umbilical catheter 60 is secured by the top clip 960, thenext segment of the umbilical catheter 60 may be secured by one of theclips 940 a-940 d. As shown in FIG. 14C, the slot 966 is oriented at anangle 970 that is 90° from a direction of the slot 901. In otherembodiments, the angle 970 may be more than 90°. Having the angle 970 tobe 90° or more is advantageous because it reduces the risk that theumbilical catheter 60 will move out of the slot 901 and become loose.

In other embodiments, the first and second clip portions 962, 964 do notfrictionally clamp the umbilical catheter 60. Instead, the first andsecond clip portions 962, 964 are sufficiently spaced apart so that theydo not clamp against the umbilical catheter 60. In such case, the topclip 960 functions to guide the umbilical catheter 60 towards a desireddirection. Thus, as used in this specification, the term “clip” is notnecessarily limit to a structure that grasp or grip an object (e.g.,catheter), and may refer to any structure that accommodates, guide,abut, or touches the object (e.g., catheter).

For example, in other embodiments, the clip 960 may have a configurationlike that shown in FIG. 19A, which includes a narrow slot 990 and alarger slot 992 (larger than slot 990). In this configuration, thecatheter 60 may first be pushed through the narrow slot 990. Once thecatheter 60 is contained in the larger slot 992, the portions definingthe narrow slot 990 (due to its width being narrower than a width of thecatheter 60) will prevent the catheter 60 from escaping larger slot 992.

Although only one top clip 960 is shown in FIG. 14A, in otherembodiments, there may be multiple top clips 960 disposed at the upperportion of the shield 20 for allowing a user to selectively pick tosecure the umbilical catheter 60.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a-940 d disposed at differentrespective sides of the shield 20. The clips 940 a-940 d are configuredto detachably hold the umbilical catheter 60 outside the shield 20. Theclips 940 a-940 d are similar or the same as those described withreference to FIGS. 12A-12C and 13A-13C, and therefore will not bedescribed again. Although four clips 940 a-940 d are shown, in otherembodiments, there may be fewer than four clips 940, or more than fourclips 940.

In other embodiments, the device 10 of FIGS. 14A-14C may include one ormore spooling groove(s) 942 as similarly described with otherembodiments herein.

In any of the embodiments described herein, the device 10 may optionallyfurther include two or more pinching protrusions (e.g., taps) forallowing a user to grasp the device 10. For example, FIGS. 15A-15Cillustrate another device 10 for protecting an umbilical stump-catheterinterface. The device 10 includes a shield 20 having a wall 22 thatdefines a cavity 24 for accommodating an umbilical stump. The shield 20further includes a base 40 for attachment to a patient. In some cases,the base 40 may include an adhesive that allows the base 40 to beattached to the patient. The device 10 includes an opening 50 at theshield 20 for allowing an umbilical catheter 60 to extend therethrough.As shown in the figures, the opening 50 is located at a top of theshield 20, and extends to a side of the shield 20, thereby defining alinear slot at the side of the shield 20. This configuration isadvantageous because it allows the shield 20 to be placed around theumbilical catheter 60 by sliding the catheter 60 through the slot at theside of the shield 20. The shield 20 can then be slid down to cover theumbilical stump.

In the illustrated embodiments, the device 10 also includes a firstpinching protrusion 980 a and a second pinching protrusion 980 b locatedon respective opposite sides from each other and at the upper portion ofthe shield 20. The pinching protrusions 980 a, 980 b are configured forallowing a user to grasp the device 10 using fingers. In otherembodiments, there may be more than two pinching protrusions. Also, inother embodiments, the pinching protrusions 980 may be located at otherareas at the shield 20.

In the illustrated embodiments, the device 10 also includes a top clip960 located at the upper portion of the shield 20 for detachablysecuring the umbilical catheter 60 relative to the shield 20. The clip960 is similar to or the same as the clip 960 described with referenceto FIGS. 14A-14C, and therefore will not be described again. Althoughonly one top clip 960 is shown, in other embodiments, there may bemultiple top clips 960 disposed at the upper portion of the shield 20for allowing a user to selectively pick to secure the umbilical catheter60.

The shield 20 also has multiple vents 800. The vents 800 may prevent a“bio-dome” like effect within the cavity of the shield 20. The vents 800may be sized and/or positioned at certain parts of the shield 20, sothat the vents 800 can allow some air exchange through the wall of theshield 20, while still allowing the shield 20 to protect the umbilicalstump by shielding off at least some bacteria. In other embodiments, theshield 20 may have only one vent 800.

In the illustrated embodiments, the shield 20 of the device 10 alsoincludes a plurality of clips 940 a-940 d disposed at differentrespective sides of the shield 20. The clips 940 a-940 d are configuredto detachably hold the umbilical catheter 60 outside the shield 20. Theclips 940 a-940 d are similar or the same as those described withreference to FIGS. 12A-12C and 13A-13C, and therefore will not bedescribed again. Although four clips 940 a-940 d are shown, in otherembodiments, there may be fewer than four clips 940, or more than fourclips 940.

In other embodiments, the device 10 of FIGS. 15A-15C may include one ormore spooling groove(s) 942 as similarly described with otherembodiments herein.

Also, as shown in FIGS. 15A-15C, the base 40 of the device 10 mayinclude a plurality of flanges 982 a, 982 b extending laterally fromsides of the shield 20. The flanges 982 a, 982 b may include adhesive atthe underneath surfaces for attachment to a patient. Additionally, oralternatively, each of the flanges 982 a, 982 b may be taped to thepatient using medical tape that extends across the top surface of theflange 982 a/982 b. The flanges 982 a, 982 b are advantageous becausethey provide an increased adhesive area for attachment to the patient,which provides a more secured attachment mechanism. Additionally, oralternatively, the flanges may be taped down to a “safe” adhesive (asdescribed previously to allow for better securement of the device whileensuring that only a “safe” adhesive interfaces with the skin.

Although only two flanges 982 are shown, in other embodiments, there maybe more than two flanges 982. For example, FIGS. 16A-16C illustrates avariation of the device 10 that includes three flanges 982 a-982 cdisposed circumferentially around the shield 20.

Also, it should be noted that the flanges 982 are not limited to havingrectangular shape like that shown in FIGS. 15-16, and that each of theflanges 982 may have other shapes in other embodiments. For example, inother embodiments, each of the flanges 982 may have a curvilinear shapelike that shown in FIG. 17, or a T-shape like that shown in FIG. 18. Inaddition, in any of the embodiments described herein, a flange 982 mayhave an anchor (e.g., along a side of the flange 982) for preventing orreducing the risk of a tape being detached from the flange 982. Inparticular, during use of the device 10, a tape may be used to tape downthe flange 982 relative to the patient, while the tape is placedunderneath the anchor at the flange 982. The anchor functions to preventthe tape from being pulled upward from the flange 982.

It should be noted that the flange feature is not limited to theembodiments shown in FIGS. 15-18, and it may be included in any of theother embodiments described herein.

Also, in any of the embodiments described herein (e.g., those describedin FIGS. 1-17), the device 10 may optionally further include an exteriorsurface configured for allowing a user to write on. For example, a topportion (e.g., a cover) of the shield 20 may have an exterior surfacethat forms a dedicated area for allowing a user to write thereon. Thededicated area may comprise a paper, which allows the user to writethereon using pencil or pen. Alternatively, the dedicated area maycomprise a plastic sheet, which allows the user to write thereon using amarker. Also, in some embodiments, the dedicated area may comprise asheet (paper, plastic, etc.) that is removably attached to the shield20.

Furthermore, in any of the embodiments described herein (e.g., thosedescribed in FIGS. 1-17), the device 10 may be made from differentmaterials. For example, a first portion of the shield 20 may be madefrom a first material, and a second portion of the shield 20 may be madefrom a second material that is different from the first material. Insome cases, the clip(s) 940 and/or the clip(s) 960 may be made from afirst material having a first durometer, and another portion of theshield 20 (e.g., the body defining the cavity 24) may be made from asecond material having a second durometer, wherein the first durometeris higher than the second durometer.

Also, in any of the embodiments described herein (e.g., those describedin FIGS. 1-17), instead of or in addition to, having the opening 50 atthe top of the device 10, the device 10 may include an opening atanother part of the device 10. For example, in other embodiments, thedevice 10 may include an opening at a side of the device 10, or at alocation that is offset from a center at the top of the device 10.

In the above embodiments, the device 10 is illustrated as being usedwith one catheter. In any of the embodiments described herein (e.g.,those described in FIGS. 1-17), the device 10 may have multiple clipsfor holding different catheters. For example, the device 10 may have afirst clip for holding a first catheter, and a second clip for holding asecond catheter. Thus, the device 10 may selectively be used with one ormore catheters. FIG. 19A illustrates another device 10 for protecting anumbilical stump-catheter interface, particularly showing the device 10being used with one catheter 60. However, the same device 10 may also beused with two (or more) catheters. As shown in FIG. 19B, the device 10is being used with two catheters 60 a, 60 b. In some cases, thecatheters may have different sizes. Thus, in some embodiments, the clipsmay have different respective sizes. For example, the first clip mayhave a first catheter slot, and the second clip may have a secondcatheter slot, wherein the first catheter slot has a dimension that isdifferent from a dimension of the second catheter slot. In otherembodiments, the clips may have the same size (e.g., the catheter slotsin the clips may have the same size). In further embodiments, the device10 may have at least three clips for holding three different respectivecatheters. In any of the embodiments described herein, two or more ofthe clips may be integrated together as a single component.

Also, as discussed, in some cases, the flanges 982 of the device 10 maybe taped down to a patient using a tape. In any of the embodimentsdescribed herein, the device 10 may optionally include one or moreanchors for preventing or reducing the risk of detachment of the tapefrom the patient. For example, as shown in the embodiments of FIG. 19Aor 19B, each flange 982 may include an anchor 996 at a side of theflange 982. During use, a tape may be placed under the anchor 996 andmay be used to tape the flange 982 onto a patient. Because the anchor996 is above the tape, it functions as an anchor that assists the tapein maintaining its position with respect to the patient.

In addition, in any of the embodiments described herein (e.g., thosedescribed in FIGS. 1-17), the device 10 may optionally further include acolor-coding and/or labeling. For example, the color coding or labelingmay indicate whether a catheter is a venous catheter or an arterialcatheter, length of catheter in the patient, etc. In one implementation,the device 10 may include a surface for allowing a nurse or physician towrite on. Also, in some embodiments, the labeling may include a singleletter indicating whether a catheter is a venous catheter (e.g., letter“V”) or an arterial catheter (e.g., letter “A”). Furthermore, in somecases, the labeling may include a number code indicating a length of acatheter.

Furthermore, in any of the embodiments described herein (e.g., thosedescribed in FIGS. 1-17), the device 10 may have a cross sectionaldimension (e.g., width of shield portion of the device 10 excluding theclips 940 and flanges 982) that is anywhere from 0.5 inch to 5 inches,and more preferably from 0.5 to 3 inches, and more preferably from 0.5to 2 inches, and even more preferably from 0.5 to 1.5 inches (e.g., 1inch). In other embodiments, the device 10 may have a cross sectionaldimension that is larger than 5 inches. Also, in any of the embodimentsdescribed herein, the device 10 may have a wall thickness that isanywhere from 0.02 inch to 0.5 inch, and more preferably from 0.05 to0.3 inch, and even more preferably from 0.06 to 0.1 inch.

In any of the embodiments described herein (e.g., those described inFIGS. 1-17), the device 10 may be made from a molding process. Forexample, injection molding, compressing molding, etc., may be used toform part(s) or an entirety of the device 10. In some cases, differentmolding processes may be used to form different parts of the device 10,and the parts may then be subsequently secured to each other (e.g.,using an adhesive, glue, etc.). Various materials may be used to formthe device 10. By means of non-limiting examples, the device 10 may beformed from thermoplastic material(s), elastomer(s), polymer(s), etc.

In any of the embodiments described herein, the spooling groove(s) isoptional, and the device 10 may not include any spooling groove. Forexample, in any of the embodiments that includes a spooling groove, suchspooling groove may be replaced with one or more clips. The clip(s) isconfigured to both hold the catheter and to define a position anddirection of travel for the catheter.

In any of the embodiments described herein (e.g., those described inFIGS. 1-17), the device 10 may include an antimicrobial component. Forexample, the device 10 itself may be made from an antimicrobialmaterial. In one implementation, the base of the device 10 includes anantimicrobial material. Alternatively, the entire device 10 may includethe antimicrobial material. In some cases, the device 10 may include aultraviolet (UV) light source coupled to the shield 20 for projecting aUV light towards the stump 30. In further embodiments, the device 10 mayinclude silver, gel, etc. that provides antimicrobial action.

In any of the embodiments described herein (e.g., those described inFIGS. 1-17), the shield 20 may be configured to deform, bend, orcollapse in response to a compression force that is less than 1 Ib, andmore preferably less than 0.5 Ib, and even more preferably less than 0.3lb. This configuration is advantageous because it allows the baby usingthe device 10 to be in various positions, such as in a facedownposition. In particular, if the baby is lying on his/her belly, thedevice 10 will deform, bend, or collapse so that the device 10 will notbe applying an uncomfortable force against the baby, while the positionof the catheter relative to the device 10 remains fixed.

In any of the embodiments described herein (e.g., those described inFIGS. 1-17), the device 10 may further include a manual controlmechanism (e.g., a clip, a knob, a pincher, etc.) configured to shut thecatheter so that fluid flow in the catheter can be stopped when desired.The manual control mechanism may be located at an exterior surface ofthe shield 20, at the base, or at any of other locations (e.g., at thedevice-catheter interface). In one implementation, a clip or a mechanismsimilar to a wingnut/bolt that is used to tighten may be provided at thedevice-catheter interface for shutting the catheter.

In any of the embodiments described herein (e.g., those described inFIGS. 1-17), the device 10 may further include a position monitoringdevice for monitoring a position of the catheter with respect to thedevice 10 (e.g., the shield 20 of the device 10). For example, theposition monitoring device may be a marking at the catheter to indicateits position relative to the shield 20. If the position has changed sothat the marking on the catheter is further from the shield 20, then itcan be inferred that the catheter has moved outward from the patient.Thus, the position monitoring device functions to monitor the depth ofthe catheter outside of the shield 20. In other embodiments, theposition monitoring device may include markers on the catheter, and acamera for viewing the markers on the catheter. Also, in furtherembodiments, similar techniques may be employed to monitor the positionof the catheter with respect to the patient or to the umbilical stump.

In some embodiments, different sizes of the device 10 may be provided.For example, there may be three standard sizes of the device 10, withthe larger size being more suitable for larger patient, and the smallersize being more suitable for smaller patient.

In any of the embodiments described herein, if the device 10 includesmultiple clips for holding different catheters, the clips may be colorcoded. For example, a first clip may have a first color, and a secondclip may have a second color that is different from the first color.Also, if the device 10 includes a clip that is configured to holdmultiple catheters, different portions of the clip may be color coded.For example, a first portion of the clip may define a space foraccommodating a first catheter, and a second portion of the clip maydefine another space for accommodating a second catheter, wherein thefirst portion and the second portion may have different respectivecolors.

Although particular embodiments have been shown and described, it willbe understood that it is not intended to limit the claimed inventions tothe preferred embodiments, and it will be obvious to those skilled inthe art that various changes and modifications may be made withoutdepartment from the spirit and scope of the claimed inventions. Thespecification and drawings are, accordingly, to be regarded in anillustrative rather than restrictive sense. The claimed inventions areintended to cover alternatives, modifications, and equivalents.

1. A device for protecting an umbilical stump-catheter interface,comprising: a shield having a wall that defines a cavity foraccommodating an umbilical stump, wherein the shield further includes abase for attachment to a patient; and an opening at the shield forallowing an umbilical catheter to extend therethrough.